CIRS put out “One-Stop” regulatory compliance service for medical devices entering into China market

Dear visitors,

Welcome! Welcome! We really would like to express our warm welcome to your coming!
When you open this page, you are opening a great value service, and you are accessing us.
We, CIRS Medical Device (MDD) Team, spent 3 years to build up the fundamental technical basis of China medical device regulations, and to build contact with authority institutes. Now, based on the customers’ requirement, and aims to favor more and more abroad outstanding medical devices and technologies entering China market, CIRS MDD team leads extensive resource and establishes this “One-Stop Regulatory Compliance Service” platform for your products.

What we do?
We do regulatory consulting, market intelligence, quality assurance, IPR protection, clinical evaluation, post-market monitoring, intellectual property right protection and adverse event tracking to global medical device and IVD manufacturers or suppliers seeking to market their product into China.
We take care of every aspect of your medical device project based on our practical experience on MDD regulatory compliance.
We maintain the whole life cycle of your products in China according to the full understanding of CFDA regulations.
We start from helping you with the pre-market investigation, and there is no ending of our service.
We do so much more for you!

What are benefits of choosing us?

• Remove language and cultural barrier;
• Avoid hiring full-time staff and lowering your compliance costs;
• Product regulatory compliance check & advice;
• Have local regulatory affairs staff clarifying your questions, analyzing the impact of any new medical device regulations on your business and assisting communication with different authorities;
• Customs clearance;
• Access CIRS MDD regulatory update report, newspaper, and all presentations free of charge.

Why not begin to navigate our web and find our service for you, or you can contact us directly at Mr. Edwin Wen | Edwen.wen@cirs-group.com or Mr. Michael Petersen | Michael@cirs-group.com. You are always welcomed to consult us!

Contact Us

Mr. Edwin Wen China office
Tel: +86 571 8720 6541 | Fax: +86 571 8720 6533
Email: Edwin.wen@cirs-group.com
Ms. Elaine Lyu Elaine@cirs-group.com